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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02309411
Registration number
NCT02309411
Ethics application status
Date submitted
24/11/2014
Date registered
5/12/2014
Date last updated
21/08/2018
Titles & IDs
Public title
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
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Scientific title
30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Young Children With Various Manifestations of Venous Thrombosis
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Secondary ID [1]
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2014-000566-22
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Secondary ID [2]
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14374
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Universal Trial Number (UTN)
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Trial acronym
EINSTEINJr
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Experimental: Rivaroxaban - Age and body weight-adjusted twice daily dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban once daily
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
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Assessment method [1]
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Major bleeding is defined as overt bleeding and:
associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or
leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or
occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or
contributing to death.
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:
medical intervention, or
unscheduled contact (visit or telephone call) with a physician, or
cessation (temporary) of study treatment, or
discomfort for the child such as pain or
impairment of activities of daily life (such as loss of school days or hospitalization).
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Timepoint [1]
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During or within 2 days after stop of study treatment (up to 32 days)
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Secondary outcome [1]
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Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
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Assessment method [1]
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Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.
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Timepoint [1]
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From start of the study treatment up to 30-days post study treatment period (approximately 60 days)
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Secondary outcome [2]
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Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
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Assessment method [2]
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The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.
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Timepoint [2]
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At the end of the 30-day treatment period
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Secondary outcome [3]
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Change From Baseline in Prothrombin Time at Specified Time Points
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Assessment method [3]
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Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline.
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Timepoint [3]
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Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
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Secondary outcome [4]
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Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
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Assessment method [4]
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The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline.
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Timepoint [4]
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Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
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Secondary outcome [5]
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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
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Assessment method [5]
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Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
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Timepoint [5]
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Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)
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Eligibility
Key inclusion criteria
- Children aged 6 months to < 6 years who have been treated for at least 2 months or, in
case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular
weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented
symptomatic or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine,
alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to
randomization
- Informed consent provided
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Minimum age
6
Months
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Maximum age
5
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
- Planned invasive procedures, including lumbar puncture and removal of non peripherally
placed central lines during study treatment
- An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
- Hepatic disease which is associated with either: coagulopathy leading to a clinically
relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x
ULN with direct bilirubin > 20% of the total
- Platelet count < 50 x 10*9/L
- Hypertension defined as > 95th age percentile
- Life expectancy < 3 months
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4)
and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors
and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole,
posaconazole, if used systemically
- Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin,
phenobarbital, phenytoin and carbamazepine
- Hypersensitivity or any other contraindication listed in the local labeling for the
comparator treatment or experimental treatment
- Inability to cooperate with the study procedures
- Previous randomization to this study
- Participation in a study with an investigational drug or medical device within 30 days
prior to randomization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/04/2017
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Sample size
Target
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Accrual to date
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Final
46
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Indiana
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Country [5]
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Austria
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State/province [5]
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Wien
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Country [6]
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Brazil
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State/province [6]
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Sao Paulo
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Country [7]
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Brazil
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State/province [7]
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São Paulo
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Hungary
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State/province [9]
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Budapest
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Country [10]
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Israel
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State/province [10]
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Jerusalem
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Country [11]
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Israel
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State/province [11]
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Ramat Gan
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Country [12]
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Italy
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State/province [12]
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Lombardia
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Country [13]
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Italy
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State/province [13]
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Piemonte
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Country [14]
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Italy
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State/province [14]
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Veneto
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Japan
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State/province [15]
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Tokyo
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Country [16]
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Netherlands
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State/province [16]
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Nijmegen
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Country [17]
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Poland
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State/province [17]
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Gdansk
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Country [18]
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Poland
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State/province [18]
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Olsztyn
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Country [19]
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Russian Federation
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State/province [19]
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Moscow
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Country [20]
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Russian Federation
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State/province [20]
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Nizhny Novgorod
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Country [21]
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Russian Federation
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State/province [21]
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St. Petersburg
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Country [22]
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Spain
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State/province [22]
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Barcelona
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Spain
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State/province [23]
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Valencia
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Country [24]
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Switzerland
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State/province [24]
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Bern
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Country [25]
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United Kingdom
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State/province [25]
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Tyne And Wear
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Country [26]
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United Kingdom
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State/province [26]
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West Midlands
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Country [27]
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United Kingdom
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Cardiff
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Research & Development, LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to find out whether rivaroxaban is safe to use in children and
how long it stays in the body. Safety will be assessed by looking at the incidence and types
of bleeding events. There will also be a check for worsening of blood clots.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02309411
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02309411
Download to PDF